tbuckley/cabot-search huggingface dataset:
Predictors of use of prevention strategies among women at high-risk for breast cancer.
Authors: Kara Landry, Ya Tuo, Emma Levine, Anya Srikureja, Marie Wood
Journal: Journal of Clinical Oncology (2022)

10554 Background: Uptake of chemoprevention and prophylactic surgery among women at high risk for breast cancer is low, despite proven efficacy. We evaluated breast cancer risk factors as predictors of uptake of prevention treatment (PT) to better understand potential associations with these decisions. Methods: An IRB approved registry established in 2003 at the University of Vermont of high-risk women was used to evaluate the association between both modifiable (obesity, sedentary lifestyle and alcohol use) and non-modifiable (age, history of benign breast disease [BDD], genetic predisposition) risk factors and uptake of PT. Women were eligible for inclusion in this analysis if they had one of the following risk factors (BDD, strong family history, &gt; 20% lifetime modeled risk or genetic predisposition) and completed questionnaires regarding diet and physical activity. Alcohol use was assessed using a health questionnaire and physical activity was assessed using a 7-Day Physical Activity Recall questionnaire. We used logistic regression to estimate odds ratios (OR). Results: 504 women were included and had been followed for median of 13 years. Mean age was 44.5 years (range 19 – 75), 98% were Caucasian, and mean BMI was 26.9 (range 17-57). 78% had a family history of breast cancer, 60% had &gt;20% lifetime modeled risk, 14% had a history of benign breast disease (BBD), and 9% of women had confirmed genetic risk in high or moderate risk genes. Women may have had more than one risk factor. 55% were physically active and 55%. 4.2% were sedentary and 12.3% consumed &gt; 1 alcoholic beverage daily. 20.8% of the cohort participated in PT (8.1% took chemoprevention, 2.0% underwent prophylactic bilateral total mastectomy and 10.7% underwent risk reducing salpingo-oophorectomy). Among non-modifiable risk factors, age, genetic predisposition (OR adj 8.66, 95% CI 2.30–32.33, p &lt; 0.0001), and history of benign breast disease (OR adj 4.09, 95% CI 1.89–8.86, p &lt; 0.001) were associated with uptake of PT. Increasing age was associated with increasing uptake (ptrend was &gt; 0.0001) and highest among women aged 60-69 years (OR adj 8.19, 95% CI 2.87-23.37 relative to women aged &lt; 40). Women with a strong family history were significantly less likely to take up PT (p = 0.04). BMI, physical activity status and alcohol use were not associated with uptake of PT. Conclusions: Like other studies, we found a low uptake of PT among women at high risk for developing breast cancer. We found that modifiable risk factors were not associated with uptake of PT, which might suggest that high-risk women with modifiable risk factors could be targeted for interventions designed to modify risk (i.e. chemoprevention, weight reduction, etc). Interestingly, women with a strong family history may be less likely to take up PT, and studies to further examine this relationship may identify opportunities for interventions to improve uptake.
Real-world analysis of the impact of race on immunotherapy in non-small cell lung cancers.
Authors: Matthew Lee, Emily Miao, Shuai Wang, Frank Zhang, John X Wei, Julie Chung, Xiaonan Xue, Balazs Halmos, Haiying Cheng
Journal: Journal of Clinical Oncology (2022)

e18692 Background: Immunotherapy (IO) has become an essential component in the treatment of NSCLC. However, there is limited data on the clinical impact of IO in distinct ethnic minorities who have been greatly under-represented in previous IO trials. It remains unclear whether Black patients carry similar characteristics and responses compared to Non-Black patients. Methods: Patients who were diagnosed with NSCLC from 1/1/2013 to 12/31/18 and confirmed to have received IO were identified from the Montefiore cancer network. Black and Non-Black patients’ characteristics were compared in patient clinical and socioeconomic variables by chi-squared, Mann-Whitney tests and two sample t-tests. Overall survival (OS) and progression free survival (PFS) were evaluated by Kaplan-Meier survival analysis and log-rank analysis using R 4.1.2 version. Results: Of the 108 patients that were analyzable, overall median age was 67 (range 45-86) years old, 35% were Black, 80% smokers/former smokers, 73% were metastatic, 53% treated with PD-l/PD-L1 inhibitor-based IO alone and 65% on first-line immunotherapy regimens. PD-L1 testing were performed in 88 (81%) of patients, including 33 (87%) Black and 55 (79%) Non-Blacks. PD-L1 TPS≥1% was found in 26 (68%) of Blacks and 42 (60%) of Non-Blacks but no significant difference between the two groups (p = 0.792). Overall, median follow-up time was 19.7 months, 50% of patients had disease control with either a complete/partial response or stable disease within 3 months of starting IO but again was not significantly different between Black and Non-Black patients (p = 0.591). Furthermore, there was no significant difference in PFS (8.2 vs. 6.2 months, p = 0.210) and OS (10.9 vs. 9.8 months, p = 0.438). Nevertheless, there was a significantly longer duration of IO in the Blacks (median 7.4 months) compared to the Non-Blacks (3.9 months) (p = 7.17E-07) (Table). Conclusions: Although the response and survival outcomes of IO were not significantly different between Black and Non-Black patients, the duration of IO is significantly longer in Black patients. This finding warrants further exploration on the reasoning behind this which may include different toxicity, tolerability or physiological characteristics.[Table: see text]
Regorafenib combined with transarterial chemoembolization and PD-1 antibody as a second-line therapy for hepatocellular carcinoma: A real-world study.
Authors: Tao Pan, Mingsheng Huang
Journal: Journal of Clinical Oncology (2022)

e16167 Background: The benefits and tolerability of regorafenib combined with transarterial chemoembolization (TACE) and programmed death-1 (PD-1) antibody as a second-line therapy for advanced hepatocellular carcinoma (HCC) is unclear. We aimed to determine the efficacy and safety of regorafenib combined with TACE and PD-1 antibody as second-line treatment for advanced HCC. Methods: This study was approved by our institutional review board. In this retrospective study, a total of 55 consecutive advanced HCC patients who had tumor progression after first-line sorafenib treatment, and then treated with regorafenib plus TACE and programmed death-1 (PD-1) antibody between January 2017 and December 2020 were evaluated. The overall survival (OS), tumor response and adverse events (AEs) were analyzed. Statistical analysis was performed with the Kaplan-Meier method using the log-rank test and Cox regression models. Results: The median follow-up period was 35.5 months (range 6.0-52.0 months). The median age was 50 (range 18, 72) years. There were 49 (89.0%) males. The initial doses of regorafenib were 80 mg/d (n = 18, 32.7%) and 120 mg/d (n = 37, 67.3%). The patients underwent a median of two TACE sessions (range 1–5). The median OS after second-line treatment was 16.0 months (range 3.6-33.5 months), and the median PFS was 9.0 months (95%CI 6.1-11.7 months). According to modified RECIST criteria, complete response and partial response were found in 3 (5.5%) and 29 (45.5%) patients. The incidence of all grade 3/4 AEs was 29.6%, and the three main AEs were abdominal pain (10.9%), hypertension (7.3%) and hand-foot-skin reaction (5.5%). Two patients stopped PD-1 antibody and one stopped regorafenib due to AEs. Conclusions: Regorafenib combined with TACE and PD-1 antibody were tolerable and resulted in a promising OS and ORR in the second-line treatment of advanced HCC.
Results for patients with muscle-invasive bladder cancer (MIBC) in the CheckMate 274 trial.
Authors: Alfred Witjes, Dean F. Bajorin, Matt D. Galsky, Jürgen E. Gschwend, Yoshihiko Tomita, Thierry Lebret, Begoña Pérez-Valderrama, Aristotelis Bamias, Sandra Collette, Joshua Zhang, Federico Nasroulah, Shahrokh F. Shariat
Journal: Journal of Clinical Oncology (2022)

4585 Background: In the CheckMate 274 trial, disease-free survival (DFS) was significantly improved with nivolumab (NIVO) vs placebo (PBO) both in intent-to-treat (ITT) patients (pts) (hazard ratio [HR], 0.70; 98.22% confidence interval [CI], 0.55–0.90; P &lt; 0.001) and in pts with tumor programmed death ligand 1 (PD-L1) expression ≥ 1% (HR, 0.55; 98.72% CI, 0.35–0.85; P &lt; 0.001). We report results for the subgroup of pts with bladder cancer, the most predominant type of urothelial carcinoma. Methods: CheckMate 274 is a phase 3, randomized, double-blind trial of adjuvant NIVO vs PBO in high-risk muscle-invasive urothelial carcinoma (bladder, ureter, renal pelvis) after radical resection. Pts were randomized 1:1 to NIVO 240 mg intravenously every 2 weeks or PBO for ≤ 1 year of adjuvant treatment and stratified by nodal status, prior neoadjuvant cisplatin, and tumor PD-L1 expression. Pts had radical resection ± neoadjuvant chemotherapy and were at high risk of recurrence on final pathologic staging. Primary endpoints were DFS in ITT pts and in pts with PD-L1 ≥ 1%. Non–urothelial tract recurrence-free survival (NUTRFS) was a secondary endpoint, and distant metastasis-free survival (DMFS) was an exploratory endpoint. This exploratory analysis focused on the subgroup of pts with muscle-invasive bladder cancer (MIBC) after radical resection. Results: Of 709 randomized pts in the trial, 560 had MIBC (NIVO, n = 279; PBO, n = 281). With a minimum follow-up of 11.0 months, a DFS benefit was observed with NIVO vs PBO in these pts, regardless of tumor PD-L1 expression (Table). DFS probability at 12 months in all MIBC pts was 66% with NIVO and 45% with PBO. DFS was improved with NIVO vs PBO across subgroups according to age, sex, ECOG performance status, nodal status, and PD-L1 expression status. Improvement in NUTRFS and DMFS with NIVO vs PBO was also observed (Table). Grade 3–4 treatment-related adverse events occurred in 17% and 6% of pts in the NIVO and PBO arms, respectively. Conclusions: Improvement in DFS was observed with NIVO over PBO in pts with MIBC after radical resection regardless of tumor PD-L1 expression. The DFS benefit was observed in all prespecified subgroups. These results further support adjuvant NIVO as a standard-of-care treatment for pts with high-risk MIBC after radical resection ± neoadjuvant cisplatin-based chemotherapy. Clinical trial information: NCT02632409. [Table: see text]
Safety, efficacy and survival outcome of Ado-trastuzumab emtansine (T-DM1) in patients with metastatic HER2-positive breast cancer: An Indian experience.
Authors: Ajay Gogia, Anshul Gupta, S.V.S. Deo, Dayanand Sharma, Sandeep Mathur
Journal: Journal of Clinical Oncology (2022)

e13008 Background: Ado-trastuzumab emtansine (T-DM1) is the standard of care for patients with advanced HER2 positive breast cancer (BC) patients who progress on the first line anti-HER2 therapy or relapse within 6 months of adjuvant trastuzumab. There is a lack of data regarding the safety and efficacy of T-DM1 in the Indian population. Methods: This retrospective study aims to evaluate the efficacy and toxicity of T-DM1 in advanced HER2 positive female BC patients, registered at All India Institute of Medical Sciences, (AIIMS) New Delhi, India, between the years 2015-2021. The response was evaluated by Response evaluated Criteria in Solid Tumors(RECIST 1.1)guidelines. Progression-free survival (PFS) was calculated from the beginning of treatment with T-DM1 until disease progression or death from any cause. Overall survival (OS) was calculated from the beginning of treatment with T-DM1 until death from any cause. Results: This study included eighty patients with a median age of 49 years (27-73). Forty-four (55%) were premenopausal and hormone receptor positivity (either ER or PR) was found in 36 (45%) cases. The ECOG performance status was 0-1in 80% of patients. De- novo metastatic disease was found in 38(47.5%) cases whereas the remaining 42 (52.5%) patients were diagnosed with early or locally advanced disease and later become metastatic. The sites of metastasis were lungs in 26 (32.5%), brain in 23 (28.7%) liver in 23 (28.7%), bones in 18 patients (22.5%), lymph nodes in 15(18.7%), cutaneous and other rare sites in 8(10%) cases. All patients had received trastuzumab in the prior line of treatment and 18 (22.5%) patients had also received pertuzumab along with trastuzumab. The median number of T-DM1 cycles given was 9 (range 3-35). The overall response rate was 80%, 8(10%) achieved a complete response, 36 (45%) had a partial response, and 12 (15%) patients had stable disease. The Grade 3/4 toxicities were observed in 20(25%) cases and these were: thrombocytopenia 16 (20%), fatigue 10 (12.5%), transaminitis 10(12.5%), anemia 2 (2.5%), and peripheral neuropathy in 2 (2.5%) cases. Dose delay, interruption, and modification were observed in 25 (31.2%) cases. Within the median follow-up period of 18 months, the median PFS was 10 months and OS was 27 months. Hormone status (ER/PR) and prior pertuzumab therapy did not influence the outcome. Conclusions: This is the first study from the Indian subcontinent on T-DM1. It is safe and effective in our population and has shown comparable outcomes with the available literature however, higher rates of thrombocytopenia were observed.
Demographic and socioeconomic factors associated with stage at diagnosis in non–small cell lung cancer: An NCDB analysis.
Authors: Kiana Verplancke, Alexandra Taylor, Jillian Marie Gallegos, Kevin McMahon, Zachary Creech, Gia Thinh Truong, Peter T. Silberstein, Mary Elizabeth Dahl
Journal: Journal of Clinical Oncology (2022)

9132 Background: There were 2.21 million new diagnoses of lung cancer worldwide in 2020, accounting for approximately 25% of all cancer related deaths. A factor that impacts the overall mortality of lung cancer is the stage at initial presentation for diagnosis. Current 5-year survival estimates of non-small cell (NSC) lung cancer range from 73% in early-stage disease to 13% in advanced disease. The stark differences in survival rate in early and late disease, highlight the importance of determining if socioeconomic and demographic factors impact the stage of cancer at diagnosis. This study sought to determine if certain socioeconomic and demographic factors are associated with receiving an early (Stage 0-I) or delayed (Stage IV) diagnosis of NSC lung cancer. Methods: Using the National Cancer Database, 1,149,539 patients were identified as having a NCDB Analytic Stage Group diagnosis of Stage 0-I (early) vs Stage IV (delayed/advanced) NSC lung cancer between 2004 and 2018. Using SPSS statistics 27, patients with early and delayed diagnoses were compared to each other based on certain characteristics including sex, race, ethnicity, and level of education. Results were analyzed using multivariate and chi square analyses, as well as one-way ANOVA. Results: We identified significant differences (p &lt;.005) between stage at presentation and certain socioeconomic factors. Females were 70% less likely to be diagnosed with advanced disease in comparison to males (p &lt;.001, 95% CI =.697-.708). African Americans and Native Americans were more likely to present with advanced disease in comparison to white patients (p &lt;.001, 95% CI = 1.407-1.449 and 1.046 – 1.235, respectively). Hispanic patients were 49.3% more likely to present with advanced disease than non-Hispanic patients (p &lt;.001, 95% CI = 1.389 – 1.605). Patients with at least one comorbidity (CCI score ≥ 1) were less likely to present with advanced disease (p &lt;.001). Those who lived in a zip code where 21% or more of the residents lacked a high school degree were more likely to present with stage IV disease, in comparison to patients who lived in a zip code where less than 20.9% of its residents did not graduate from high school (p &lt;.001). Conclusions: Demographic and socioeconomic factors associated with a delayed diagnosis of NSC lung cancer include male sex, non-white race, being Hispanic, having no comorbidities, and living in a zip code where 21% or more residents have no high school degree.
Impact of therapeutic strategy on disease-free and overall survival of early-stage cervical cancer: Surgery alone <i>versus</i> preoperative radiotherapy.
Authors: Katia Mahiou, Laura Vincent, Karine Peignaux-Casasnovas, Hélène Costaz, Marie-Martine Padeano, Alix Amet, Tienhan Sandrine Dabakuyo, Leila Bengrine-Lefevre, Charles Coutant
Journal: Journal of Clinical Oncology (2022)

e17517 Background: At present, there is no international consensus for management of early-stage cervical cancer. This study aimed to retrospectively investigate disease-free survival (DFS) and overall survival (OS) in patients with early cervical cancer according to the therapeutic strategy used, surgery alone versus pre-operative radiotherapy following by surgery. Methods: Data from patients with early-stage cervical cancer were retrospectively collected from January 1998 to December 2015 using the Breast &amp; Gynecological Cancer Registry of the Côte d’Or, regrouping data from 7 centers. The inclusion criteria were: FIGO 2009 stage IB1 or lower; epidermoid, adenocarcinoma or adenosquamous type. The exclusion criteria were: history of pelvic radiation; concomitant radiochemotherapy; adjuvant radiotherapy; total radiation dose less than 50 Gy, or more than 66 Gy or not documented. In the surgery group, patients had only a surgical treatment for early-stage cervical cancer. The surgical treatment was either a hysterectomy, a trachelectomy or a conization. In the radiation group; patients had radiotherapy, brachytherapy and/or radiotherapy followed by surgery. DFS and OS were determined using the Kaplan-Meier method .Survival curves were compared using the log-rank test. Results: A total of 126 patients were included. Median survival in the whole population was 90 months (47-148); 72 months for those receiving primary surgery, and 135.5 months for those receiving primary radiation therapy. There was no significant difference in DFS between the surgery and radiation groups (HR=2.82, 95%CI (0.82-9.65), p=0.08). Similarly, there was no significant difference in OS between groups (HR=1.35, 95%CI (0.6-3.05), p=0.5). In the sub-group of patients with stage IB1 (FIGO 2009), there was no significant difference in DFS (HR=3.26, 95%CI (0.4-26.76), p=0.2) or in OS (HR=3.87, 95%CI (0.49-30.35), p=0.2) between groups. Conclusions: Cervical cancer counts among the only solid tumors for which increasing mortality has been observed in recent years. Radiation therapy is still a major source of morbidity for young patients. Therefore, key issues remain outstanding for the future management of young patients with cervical cancer and include reducing the morbidity of existing therapeutic options by identifying subgroups of patients at low or intermediate risk, and facilitating fertility-sparing surgery.
Can personality feedback improve the process of self-management in cancer? Results from a randomized controlled trial.
Authors: Laura M Perry, Brenna Mossman, Catherine Rochefort, Leah E Walsh, Ashley B Lewson, Michael Hoerger
Journal: Journal of Clinical Oncology (2022)

12130 Background: Although personality characteristics predict emotional and physical quality of life in cancer, personality assessments are rarely used to inform care. This study examined whether a personality feedback intervention improved three patient-reported outcomes underlying the process of cancer self-management: 1) self-awareness, 2) self-efficacy for managing symptoms, treatment/medication, and emotions, and 3) positive affect. Methods: A sample of 372 adults with a history of cancer participated in a single-session, pre-post randomized controlled trial via Qualtrics (Control n= 188, Intervention n= 184). The sample was recruited online through ResearchMatch.org and cancer social media sites. Participants completed a baseline survey of demographics, Big Five personality traits, and study outcomes using validated measures. Next, they were immediately randomized to receive either intervention or control materials, followed by a post-test of study outcomes. Intervention participants received a feedback report of their personality results and tailored self-management tips, while control participants received only a general description of the Big Five personality traits. Three general linear models tested between-group differences in changes from baseline to post-test on each outcome, while controlling for baseline scores and demographic and health characteristics. Significance thresholds for all coefficients across all three models were simultaneously adjusted for a false discovery rate of 15%. Intervention participants also responded to a 5-item acceptability scale. Results: Participants were mostly non-Latino/a White (91%), middle-to-older aged ( M= 58.40, SD= 13.56), women (72%), and diagnosed with cancer an average of 6.06 years prior ( SD= 3.91). Compared to controls, intervention participants experienced a greater increase on a composite measure of self-efficacy for illness self-management ( d= 0.32, p=.002), as well as on the individual domain of self-efficacy for managing symptoms ( d= 0.36, p&lt;.001). Contrary to hypotheses, the intervention did not improve self-awareness or positive affect ( ps ≥.132). Intervention participants rated the activity’s acceptability a mean of 3.97 ( SD= 0.68) on a scale from 1 to 5. Conclusions: This was the first study to demonstrate that a personality feedback intervention can improve self-efficacy in the context of managing a chronic illness. Findings call for follow-up studies to test whether these results translate into improved self-management behaviors and quality of life among individuals living with cancer. Clinical trial information: NCT04625439.